Director, Study Start Up United Kingdom

Overview

In this Director of Study Start Up role, you will oversee SSU performance and regional teams to drive timely trial start-up activities. You will partner with leadership to standardize global SSU processes, manage staffing and resources, and ensure contractual and regulatory compliance across regions. You will lead cross-border collaboration to align regional goals, mitigate risk, and accelerate delivery of life-saving medical innovations. This is a high-impact role for shaping SSU capabilities in a fast-moving biotech, medtech and pharma environment.

Responsibilities

• Provide regional SSU oversight and team leadership
• Manage staffing and resources to optimize departmental utilization
• Drive SSU teams to meet project timelines
• Support SSU team development: knowledge, presentation skills, accountability
• Partner with VP to improve and streamline global SSU efficiencies and processes
• Collaborate with SSU management across US and other regions for consistency
• Ensure proactive SSU processes aligned with contractual obligations
• Apply risk management principles

Key requirements

• Bachelor’s degree in clinical, scientific or health related field
• 7-9 years in health sciences; clinical trials support or pharma industry experience preferred
• Direct SSU experience highly preferred
• 5-7 years in personnel management overseeing larger teams
• Expertise in ICH/GCP and/or ISO14155, regulatory drug/device R&D knowledge
• Working knowledge of FDA, European Regulatory and EC procedures
• Knowledge of site and institution specific contract requirements

• leadership and people management
• cross-functional collaboration
• communication and presentation skills
• ICH/GCP
• ISO14155
• regulatory knowledge for FDA/European procedures

…